Hostname: page-component-586b7cd67f-2brh9 Total loading time: 0 Render date: 2024-11-27T22:02:16.080Z Has data issue: false hasContentIssue false
  • English
  • Français

EARLY DIALOGUE WITH HEALTH TECHNOLOGY ASSESSMENT BODIES: A EUROPEAN PERSPECTIVE

Part of: Special Collection - Methods

Published online by Cambridge University Press:  30 March 2015

Matthieu Cuche ,
Rachel Beckerman ,
Cyrus A. Chowdhury  and
Marije A. van Weelden
Matthieu Cuche
Affiliation:
Covidien, [email protected]
Rachel Beckerman
Affiliation:
CBPartners, [email protected], [email protected]
Cyrus A. Chowdhury
Affiliation:
CBPartners, [email protected], [email protected]
Marije A. van Weelden
Affiliation:
Ferring, [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction: Evidence requirements may differ across HTA bodies, and so pharmaceutical companies must plan to synergize their evidence generation strategy, across global regulatory and HTA bodies. Until recently, companies had no official platform to discuss the clinical development of a drug with HTA bodies; however, this is changing.

Objectives: To achieve broad usage in the EU, products must achieve both regulatory and reimbursement approval, the latter of which is based on HTA appraisal in many markets. The objective of this study is to present and evaluate the different options available for early HTA consultation (during drug development/Phase III) in the major European markets from the industry perspective.

Methods: An exploratory (nonsystematic) literature review was performed to identify the European markets offering early HTA consultations, and each process was analyzed using a set of predefined metrics that are relevant to industry (the ability to consult with the regulatory body in parallel, consultation fees, length of consultation meeting, language of consultation meeting, maximum number of pharmaceutical company employees attending, procedural timelines, nature of data for which consultative advice can be sought, the output of the process, and the ability to involve external experts).

Results: Four different types of early HTA consultation processes were identified across the major European HTA markets. The nature of these processes varied in terms of the types and number of questions that can be addressed, the length of the meeting, the reporting output, and the ability to involve external experts.

Conclusions: The availability of various options for early HTA consultation may help to avoid a mismatch between the evidence generated by means of a product's clinical development program, and the evidence expected by HTA bodies and payers, which can facilitate the pricing and reimbursement process upon a product's market authorization.

Keywords

ReimbursementDecision makingTechnology assessmentBiomedical/economicsHealth policy/economicsInsuranceHealthReimbursement/economicsScientific consultationEarly dialogueClinical developmentMarket access
Type
Methods
Information
International Journal of Technology Assessment in Health Care , Volume 30 , Issue 6 , December 2014 , pp. 571 - 578
Copyright
Copyright © Cambridge University Press 2015 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. European Medicines Agency. Yervoy. 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002213/human_med_001465.jsp&mid=WC0b01ac058001d124 (accessed May 3, 2013).Google Scholar
2. Scottish Medicines Consortium. Ipilimumab (Yervoy®) 5mg/mL concentrate for solution for infusion, SMC No. (779/12). Glasgow: Scottish Medicines Consortium; 2011.Google Scholar
3. National Institute for Clinical Excellence. Ipilimumab: Appraisal consultation. London: NICE; 2011.Google Scholar
4. National Institute for Clinical Excellence. Ipilimumab for previously treated advanced (unresectable or metastatic) melanoma. London: NICE; 2012.Google Scholar
5. Scottish Medicines Consortium. Ipilimumab (Yervoy®) 5mg/mL concentrate for solution for infusion, SMC No. (779/12). Glasgow: Scottish Medicines Consortium; 2013.Google Scholar
6. Gemeinsame Bundesausschuss. Beschlusse uber die Nutzenbewertung von Arzneimitteln mit neuen Wirkstoffen nach § 35a des Funften Buches Sozialgesetzbuch (SGB V): Linagliptin. 2012.Google Scholar
7. Bruce, F. No hope for BI/Lilly's Trajenta in Germany, but will prescribers care? 2013. http://www.scripintelligence.com/home/No-hope-for-BILillys-Trajenta-in-Germany-but-will-prescribers-care-340249 (accessed May 9, 2013).Google Scholar
8. Beckerman, R, Chowdhury, CA. Payer prophecy: Pricing and access optimisation by trial design. 2012. CBPartners. http://www.cbpartners.com/thoughtleadership/PR%20Optimised%20Trial%20Design.pdf (accessed June 2013).Google Scholar
9. Backhouse, ME, Wonder, M, Hornby, E, et al. Early dialogue between the developers of new technologies and pricing and reimbursement agencies: a pilot study. Value Health. 2011;14:608–615.CrossRefGoogle ScholarPubMed
10. Silverman, E. Clinical trials costs are rising rapidly. 2011. Pharmalot. http://www.pharmalive.com/clinical-trial-costs-are-rising-rapidly (accessed May 6, 2013).Google Scholar
11. Dental and Pharmaceutical Benefits Board (TLV). Joint scientific advice meetings between the Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Products Agency (MPA). 2010. http://www.lakemedelsverket.se/english/product/Medicinal-products/Scientific-advice/Pilot-project-of-joint-scientific-advice-meetings-arranged-by-the-TLV-and-the-MPA/ (accessed May 7, 2013).Google Scholar
12. Federal Joint Committee. The benefit assessment of pharmaceuticals in accordance with the German Social Code, Book Five (SGB V), section 35a. 2011. http://www.english.g-ba.de/benefitassessment/information/#9 (accessed May 7, 2013).Google Scholar
13. National Institute for Clinical Excellence. NICE scientific advice. 2012. http://www.nice.org.uk/aboutnice/scientificadvice/AboutScientificAdvice.jsp (accessed May 7, 2013).Google Scholar
14. College voor zorgverezekeringen. CVZ - Scientific Advice. 2013. http://www.cvz.nl/zorgpakket/cfhagenda/commissie/wetenschappelijk+advies/wetenschappelijk+advies.html (accessed May 7, 2013).Google Scholar
15. Pavlovic, M. Early dialogues: EUnetHTA JA2 WP7. 2012. http://www.topra.org/sites/default/files/assets/pdf/pavlovic.pdf (accessed May 7, 2013).Google Scholar
16. EUnetHTA. Final minutes of EMA/EUnetHTA meeting. 2013. EUnetHTA. http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/EUnetHTA-EMA%20f-t-f%20meeting%20summary%2020130514%20London%20UK.pdf (accessed June 14, 2013).Google Scholar
17. Moseley, J. HTA-EMA scientific advice. 2012. Presented at the TOPRA Annual 2012 Symposium. Dublin, Ireland. October 1, 2012.Google Scholar
18. Tapestry Networks. Pilots of multi-stakeholder consultations in drug development. 2012. http://www.tapestrynetworks.com/initiatives/healthcare/upload/Pilots-of-multi-stakeholder-consultations-in-drug-development-6-June-2012.pdf (accessed June 4, 2013).Google Scholar
19. Hutton, J, Trueman, P, Facey, K. Harmonization of evidence requirements for health technology assessment in reimbursement decision making. Int J Technol Assess Health Care. 2008;24:511–517.Google Scholar
20. Wonder, M, Backhouse, ME, Hornby, E. Early scientific advice obtained simultaneously from regulators and payers: findings from a pilot study in Australia. Value Health. 2013;16:1067–1073.Google Scholar
Supplementary material: File

Cuche supplementary material

Figure S1

Download Cuche supplementary material(File)
File 64.6 KB